Bevacizumab and the risk of arterial and venous thromboembolism in patients with metastatic, castration‐resistant prostate cancer treated on Cancer and Leukemia Group B (CALGB) 90401 (Alliance)
Year: 2014
Type: article
Abstract: BACKGROUND: Bevacizumab is associated with an increased risk of arterial thromboembolism (ATE); however, its effect on venous thromboembolism (VTE) remains controversial. Scant data exist on the factors that increase the risk of ATE/VTE in patients with prostate cancer. The authors investigated the association of bevacizumab treatment and clinical factors with ATE/VTE risk in patients who were treated on Cancer and Leukemia Group B (CALGB) trial 90401. METHODS: Patients with metastatic, castration-resistant prostate cancer were randomized to receive docetaxel and prednisone with or without bevacizumab once every 21 days. Cycle-to-event Cox regression models were used to investigate the association of bevacizumab with the incidence of grade 3 or greater (≥ 3) ATE and VTE. Age, prior ATE/VTE, baseline antiplatelet/anticoagulant use, and VTE risk score (based on leukocyte count, hemoglobin, platelet count, body mass index, and tumor location) were evaluated in univariate and multivariable analyses. RESULTS: Of 1008 randomized patients, the odds of experiencing grade ≥ 3 ATE were significantly greater in those who received bevacizumab compared with those who received placebo (odds ratio, 2.79; P = .02), whereas an opposite trend was noted for grade ≥ 3 VTE (odds ratio, 0.60; P = .08). In the multivariable analysis, bevacizumab treatment (hazard ratio [HR], 3.00; P = .01) and age (HR, 1.06; P = .02) were significantly associated with the risk of ATE; whereas age (HR, 1.05; P = .01) and VTE risk score (HR, 1.83; P = .03) were significantly associated with the risk of VTE. CONCLUSIONS: Bevacizumab was significantly associated with a greater risk of ATE in patients with metastatic, castration-resistant prostate cancer, but it was not significantly associated with the risk of VTE. Understanding clinical factors that increase the risk for experiencing ATE/VTE is essential to mitigate the risks and reduce the burden of these prevalent complications in cancer care.
Source: Cancer
DOI: 10.1002/cncr.29169
Institutions: Carolinas Healthcare System, Levine Cancer Institute, Duke University, University of Michigan, University of Chicago, University of California, San Francisco, Johns Hopkins University, Johns Hopkins Medicine, Duke Medical Center, Memorial Sloan Kettering Cancer Center, Thomas Jefferson University Hospital, Moffitt Cancer Center
Language: English
Subfield: Internal Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G10814802, Alliance Statistics and Data Management Center, Cancer and Leukemia Group B, G187421119, ECOG-ACRIN Network Group Operations Center, G192656225, G199746015, G2296793909, G2647518335, Johns Hopkins University NCTN Lead Academic Site Program, Cancer and Leukemia Group B Statistical Center, Functional Polymorphism Analysis in Drug Pathways, G332150848, Eastern Cooperative Oncology Group, Genetic Etiology of Cancer Drug Response, G4205753748, Pharmacogenomics of Membrane Transporters, CANCER AND LEUKEMIA GROUP B, Cancer and Leukemia Group B, G5765316850, Cancer and Leukemia Group B, PAAR-Pharmacogenomics of Anticancer Agents Research Group, NCTN Lead Academic Participating Sites Application, A Knowledge Base for Clinically Relevant Genes and Variants, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group Operations Office, Pharmacogenetics of Membrane Transporters, Alliance for Clinical Trials in Oncology Operations Center, G9000028455, G9000096334, G9000113362, G9000267065, Cancer Center Support Grant, Moffitt Cancer Center Support Grant, Regional Oncology Research Center, Integrative Molecular Epidemiology Workshop, G964706321, G973482110
OpenAlex ID: W1592369701